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Non-invasive Current Stimulation for Restoration of Vision

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ClinicalTrials.gov Identifier: NCT04008589
Recruitment Status : Active, not recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
ERA-NET
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg

Brief Summary:
The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters that allow concluding about the mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.

Condition or disease Intervention/treatment Phase
Stroke Electrical Stimulation Device: repetitive transorbital AC Stimulation Device: combination of transcranial direct current stimulaton and rtACS Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: rtACS
repetitive transorbital ACS
Device: repetitive transorbital AC Stimulation
Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

Device: combination of transcranial direct current stimulaton and rtACS
Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Experimental: tDCS/rtACS
Sequential tDCS - tACS
Device: repetitive transorbital AC Stimulation
Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

Device: combination of transcranial direct current stimulaton and rtACS
Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Sham Comparator: Sham stimulation Device: repetitive transorbital AC Stimulation
Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

Device: combination of transcranial direct current stimulaton and rtACS
Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS




Primary Outcome Measures :
  1. Size of the visual field [ Time Frame: 2 weeks ]
    Mean threshold in standard static perimetry and and detection accuracy in HRP


Secondary Outcome Measures :
  1. Resting EEG power spectra [ Time Frame: 2 weeks ]
    EEG measurement using 128 channel



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HH due to ischemic or hemorrhagic stroke
  • age between 18 and 75 years
  • lesion age at least 6 months
  • stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
  • presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
  • best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

  • known active malignancy
  • eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
  • electric or electronic implants (e.g. heart pacemaker)
  • metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
  • expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
  • epileptic seizure within the last 10 years
  • use of antiepileptic or sedative drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008589


Locations
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Germany
Institute of Medical Psychology
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
ERA-NET

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Responsible Party: Bernhard A. Sabel, Prof., University of Magdeburg
ClinicalTrials.gov Identifier: NCT04008589     History of Changes
Other Study ID Numbers: REVIS
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data will be avalaible without restriction
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After the publication of the data
Access Criteria: Contact to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases